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Sanjiv Shankaran

CHENNAI, June 16

THE Union Government's sincerity in implementing the Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 2005 would hold the key to attracting business in clinical trials of drugs to India, say pharmaceutical industry experts.

According to Dr Ashok Kumar, Director, Spectra Clinical Research Centre, the country is well positioned to attract an increasing volume of clinical trial business. The only obstacle could be a delay or insincerity on the part of the Government in implementing its WTO-related obligations such as TRIPS that aim to protect commercial data, among other things.

Clinical trials for drugs are rigorously controlled experiments conducted on human volunteers after a long phase of animal testing (preclinical stage). Data from clinical trials are scrutinised by the relevant regulator for safety, among other factors, before a drug can be sold.

Clinical trial business has begun to flow into India. Spectra, for instance, has a business alliance with the Apollo Hospitals group to handle its clinical trial work. Spectra is an independent entity that acts as a site management organisation (SMO) (entity that handles the nitty-gritty of the trial process).

A tangible idea of the potential was provided by the market research agency, AC Nielsen ORG-MARG, in its 2002 report on the Indian pharmaceutical market. The report indicated that two-third of global R&D cost of $40 billion is in drug development. Outsourcing of preclinical and clinical research accounts for nearly $13 billion.

Overseas pharmaceutical companies would generate clinical trial business in India. Escalating cost of research & development (R&D) has sparked the tendency to carry out clinical trials in relatively low-cost destinations such as India.

According to the American research-based pharmaceutical manufacturers' association, PhRMA, the average cost to develop a new drug has grown from $138 million in 1975 to $ 802 million in 2000. The R&D cost is impacted by a high failure rate. For instance, PhRMA says that out of 250 compounds that enter preclinical testing, only one compound is finally approved.

A large patient population that battles a wide range of ailments makes India a likely destination for clinical trials. However, the rigour involved in conducting trials and data collection require the presence of other factors such as credibility and infrastructure.

On the issue of credibility, Dr Ashok Kumar said "on a global basis, it is extremely good because they have been exposed to Indians... 95 per cent, we are there". He added that India scored high on the issues of hospital infrastructure and skilled doctors too.

Clinical trials have a negative side too. In India, the business has been adversely impacted by unsavoury incidents, leading to a fear that the trial process is open to abuse.

Responding to the issue, Dr Ashok Kumar indicated that the overwhelming need to present the relevant regulator with credible data acts as a check on abuse. A pharmaceutical company would have to deal with serious consequences if abuse of the clinical trial process came to light. This factor motivates entities to adhere to the prescribed process, he said.

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